Randomized Control Trial of Usual Labor Versus Extended Second Stage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Number of Patients Delivered by Cesarean
研究概览
简要总结
The hypothesis of this study is that extending the second stage of labor beyond current American College of Obstetricians and Gynecologists suggestions can reduce the cesarean delivery rate. The cesarean delivery rate in the United States is around 30 percent. This is a number that continues to be increasing over the last few decades and will continue to climb. Each subsequent cesarean section puts the mother and baby at increased risk for postpartum hemorrhage, bowel and bladder injury, abnormal placentation, febrile morbidity and death. The most common reason for a cesarean delivery is a repeat cesarean delivery. One way to reduce this number is to prevent the first cesarean delivery. The aim of this study is evaluate if extending the second stage of labor affects the cesarean delivery rate and subsequent perinatal morbidity.
详细描述
- Consent at the time of admission or in the office
- 2nd stage starts at full dilation
- Randomization occurs at 2 hours without epidural or 3 hours with epidural, stratified by epidural status
- Randomization scheme is according to a predetermined computer-generated block randomization scheme with block sizes of 6,8 and12 (random blocks).
- Sequentially numbered and sealed opaque envelopes prepared according to the randomization scheme and delivered to a secure container in labor and delivery suite to maintain concealed treatment allocation.
- At the 3 hour mark, the next number envelope is pulled and opened by the physician/nurse to reveal the designated group. At this point the patient is considered randomized.
- Provider preference for cesarean delivery, operative vaginal delivery, continued pushing, with intention-to-treat analysis
- Those that require cesarean delivery - usual perioperative management
- Early termination criteria: emergency cesarean delivery, category 3 fetal heart tracing
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Nulliparous women
- •singleton pregnancies
- •cephalic presentation
- •36.0-41.6 weeks
- •age 18 and older
排除标准
- •Category 3 fetal heart tracing
- •major congenital anomalies
- •multiples
- •planned cesarean delivery
- •intrauterine fetal demise
- •Trial of labor after cesarean
研究组 & 干预措施
Usual Labor
Immediate delivery after 3 hours with epidural or 2 hours without epidural
干预措施: Length of Second Stage (Other)
Extended
Immediate delivery after 4 hours with an epidural or 3 hours without an epidural
Intervention: one additional hour for the second stage of labor
Length of second stage in extended arm is 3 hours without epidural and 4 hours with epidural.
干预措施: Length of Second Stage (Other)
结局指标
主要结局
Number of Patients Delivered by Cesarean
时间窗: At time of delivery, up to 4 hours of the second stage for "Extended group" and 3 hours for "Usual group"
Number of patients delivered by cesarean delivery for the extended labor group
次要结局
- Number of Newborns With Umbilical Artery pH < 7.10(at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual")
- Postpartum Hemorrhage(at time of delivery, 4 hours second stage for "Extended" 3 hours second stage for "Usual")
研究者
alexis gimovsky
Fellow in Maternal Fetal Medicine
Thomas Jefferson University